Evaluation of an Integrated Imaging System (Smart Goggles) For In Vivo Detection of Fluorescently Labeled Lymph Nodes for Breast Cancer: A Pilot Study To Visualize Sentinel Lymph Nodes After Periareolar Injection of Indocyanine Green
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard.
研究概览
简要总结
This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.
详细描述
Primary Objective -Positive fluorescence signal in SLNs imaged by the Smart Goggles system.
Secondary Objectives
- Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
- Comparison of lesions detected by the Smart Goggles vs. lesions detected using SPY/Quest/PDE vs. gold standard of gamma probe and blue dyes.
Exploratory Objectives
-Collection of preliminary data for a future, powered study for lymphatic mapping in breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects with at least 1 lesion of tumor of the breast
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Subjects who have been treated with radiation therapy on the chest.
- •Has had previous sentinel lymph node biopsy
- •Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.
结局指标
主要结局
Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard.
时间窗: At the end of the procedure, about 50 minutes
Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs.
次要结局
- Fluorescence intensity(Typically no more than 30 minutes)
- Sensitivity as measured via the ICG accumulation curve(At the end of the procedure, about 50 minutes)
- Specificity as measured via the ICG accumulation curve(At the end of the procedure, about 50 minutes)
- Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the SPY/Quest/PDE imaging systems.(At the end of the procedure, about 50 minutes)
- Number of samples with ICG detected in biopsy tissue(At the end of the procedure, about 50 minutes)
- Number of removed lymph nodes with cancer cells(At the end of the procedure, about 50 minutes)
- Number of samples with lymph node detected in biopsy tissue(At the end of the procedure, about 50 minutes)
- Number of surgeons who prefer interventional device vs current near-infrared (NIR) cameras(At the end of the procedure, about 50 minutes)